Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737147
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2023-02-12
Brief Title:
Comparison of the Accuracy and Precision of a Zero Heat Flux Thermometer SpotOn Versus Pulmonary Artery Temperature
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Comparison of the Accuracy and Precision of a Zero Heat Flux Thermometer SpotOnTM Versus Pulmonary Artery Temperature Measurement in Patients Undergoing On-pump Heart Surgery a Prospective Multicentre Observational Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we aim to compare the core temperature measured with two noninvasive ZHF thermometers and a urinary bladder thermometer against a gold standard blood temperature measured in the pulmonary artery in patients undergoing on-pump cardiac surgery Additionally we intend to compare the reproducibility of the ZHF measurements by using two devices simultaneously in each patient
Detailed Description:
Anesthesia will be induced with fentanyl propofol and rocuronium and maintained with sevoflurane and fentanyl or sevoflurane and remifentanil infusion Hypotension after induction of anesthesia will be treated primarily with phenylephrine or ephedrine and secondarily with norepinephrine infusion
After induction of anesthesia a PAC Edwards Lifescience Thermodilution Paceport Catheter 931F75 75F 25 mm 110 cm will be inserted in the pulmonary artery and connected to a Vigilance 2-monitor Core temperature at the tip of the PAC will be measured every minute and displayed on the monitor Two SpotOn ZHF temperature monitoring probes 3M Model 370 Temperature Monitoring System St Paul MN will be fixed on the skin of the left and right side of the forehead above the eyebrow before induction of anesthesia These devices also measured core temperature every minute and displayed the values on two display screens In addition a temperature-sensing indwelling urinary catheter CovidienTM Mon-a-ThermTM Foly Catheter with temperature sensor 400TM will be placed after induction of anesthesia to allow continuous drainage of urine and continuous measurement of body temperature
Core temperatures measured by PAC ZHF-thermometer and bladder thermometer will be recorded with an interval of 1 minute
In all patients the core temperature are allowed to drop until going on CPB There will be no no external warming or infusion warming before CPB At initiation of CPB measurements will stop because during CPB core temperatures measured with PAC does not produce an accurate estimate of core temperature
After induction of anesthesia a PAC Edwards Lifescience Thermodilution Paceport Catheter 931F75 75F 25 mm 110 cm will be inserted in the pulmonary artery and connected to a Vigilance 2-monitor Core temperature at the tip of the PAC will be measured every minute and displayed on the monitor Two SpotOn ZHF temperature monitoring probes 3M Model 370 Temperature Monitoring System St Paul MN will be fixed on the skin of the left and right side of the forehead above the eyebrow before induction of anesthesia These devices also measured core temperature every minute and displayed the values on two display screens In addition a temperature-sensing indwelling urinary catheter CovidienTM Mon-a-ThermTM Foly Catheter with temperature sensor 400TM will be placed after induction of anesthesia to allow continuous drainage of urine and continuous measurement of body temperature
Core temperatures measured by PAC ZHF-thermometer and bladder thermometer will be recorded with an interval of 1 minute
In all patients the core temperature are allowed to drop until going on CPB There will be no no external warming or infusion warming before CPB At initiation of CPB measurements will stop because during CPB core temperatures measured with PAC does not produce an accurate estimate of core temperature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None